In 2011, the FDA ( Food and Drug Administration ) identified a possible association between breast implants and the development of anaplastic large cell lymphoma ( ALCL ), a rare type of non-Hodgkin's lymphoma.
At that time, the FDA knew of so few cases of this disease that it was not possible to determine what factors increased the risk.
Since 2011, FDA has strengthened the understanding of this condition and concur with the World Health Organization ( WHO ) designation of breast implant-associated anaplastic large cell lymphoma ( BIA-ALCL ) as a rare T-cell lymphoma that can develop following breast implants.
The exact number of cases remains difficult to determine due to significant limitations in world-wide reporting and lack of global implant sales data.
At this time, most data suggest that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces.
In 2016, there were several advances in the description of the disease and treatment recommendations. These are described below:
The World Health Organization recognized breast implant-associated anaplastic large cell lymphoma as a rare T-cell lymphoma that can develop following breast implants;
Professional organizations including the Plastic Surgery Foundation and the National Comprehensive Cancer Network ( NCCN ) published information to help physicians understand the disease and provide diagnosis and treatment;
Regulatory bodies outside the United States issued communications on BIA-ALCL;
The Australian Therapeutic Goods Administration ( TGA ) reported a detailed analysis of the 46 confirmed cases of BIA-ALCL in Australia, including 3 deaths. TGA estimated the risk of developing BIA-ALCL to be between 1-in-1000 and 1-in-10,000 women with breast implants;
The French National Agency for Medicines and Health Products Safety ( ANSM ) asked manufacturers of textured breast implants to perform biocompatibility testing ( testing to determine how living tissues react to textured implants ) and to report their findings within a year.
As of February 1, 2017, the FDA has received a total of 359 medical device reports ( MDRs ) of BIA-ALCL, including nine deaths. There are 231 reports that included information on the implant surface. Of these, 203 were reported to be textured implants and 28 reported to be smooth implants.
Most of the reports contained no information about the surface textures of any previous implants.
In addition, 312 of the 359 reports included information on implant fill types.
Of these, 186 reported implants filled with silicone gel and 126 reported implants filled with saline.
It is important to note that details on breast implant surface and fill type are limited. While the MDR system is a valuable source of information, it may contain incomplete, inaccurate, untimely, unverified, or biased data.
In addition, the incidence or prevalence of an event cannot be determined from the MDR reporting system due to potential under-reporting, duplicate reporting of events, and the lack of information about the total number of breast implants.
A significant body of medical literature has been published since our 2011 report, including additional case histories and comprehensive reviews of the natural history and long-term outcomes of the disease.
Most of the cases in the literature reports describe a history of the use of textured implants.
Several recent journal articles explore the risk factors for BIA-ALCL, including the methods used to create surface texture of the implant and the role of biofilm in causing disease, among others.
All of the information to date suggests that women with breast implants have a very low but increased risk of developing ALCL compared to women who do not have breast implants.
Most cases of breast implant-associated ALCL are treated by removal of the implant and the capsule surrounding the implant and some cases have been treated by chemotherapy and radiation.
Health Care Providers
If you have patients with breast implants, you should continue to provide them routine care and support. BIA-ALCL is a very rare condition; when it occurs, it has been identified most frequently in patients undergoing implant revision operations for late onset, persistent seroma. Because it has generally only been identified in patients with late onset of symptoms such as pain, lumps, swelling, or asymmetry, prophylactic breast implant removal in patients without symptoms or other abnormality is not recommended.
Current recommendations include the steps below:
Be aware that most confirmed cases of BIA-ALCL have occurred in women with textured breast implants. Provide the manufacturers' labeling as well as any other educational materials to your patients before surgery and discuss with them the benefits and risks of the different types of implants.
Consider the possibility of BIA-ALCL when you have a patient with late onset, persistent peri-implant seroma. In some cases, patients presented with capsular contracture or masses adjacent to the breast implant. If you have a patient with suspected BIA-ALCL, refer her to an appropriate specialist for evaluation. When testing for BIA-ALCL, collect fresh seroma fluid and representative portions of the capsule and send for pathology tests to rule out BIA-ALCL. Diagnostic evaluation should include cytological evaluation of seroma fluid with Wright Giemsa stained smears and cell block immunohistochemistry testing for cluster of differentiation ( CD ) and Anaplastic Lymphoma Kinase ( ALK ) markers.
Develop an individualized treatment plan in coordination with the patient's multi-disciplinary care team. Consider current clinical practice guidelines, such as those from the Plastic Surgery Foundation or the National Comprehensive Cancer Network ( NCCN ) when choosing your treatment approach. ( Xagena )
Source: FDA, 2017